Soma Compound

"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...

SIDE EFFECTS

The following adverse reactions which have occurred with the
administration of the individual products alone may also occur with the use of
Soma Compound (carisoprodol and aspirin) . The following events have been reported during post-approval
individual use of carisoprodol and aspirin. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.

Carisoprodol: The following events have been
reported during post-approval use of carisoprodol. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal relationship
to drug exposure.

Gastrointestinal

Aspirin: The most common adverse reactions associated with the
use of aspirin have been gastrointestinal, including abdominal pain, anorexia,
nausea, vomiting, gastritis, and occult bleeding (see WARNINGS,
Serious Gastrointestinal Adverse Reactions and PRECAUTIONS,
Gastrointestinal Adverse Reactions). Other adverse reactions associated
with the use of aspirin include elevated liver enzymes, rash, pruritus, purpura,
intracranial hemorrhage, interstitial nephritis, acute renal failure, and tinnitus.
Tinnitus may be a symptom of high serum salicylate levels (see OVERDOSAGE).

DRUG INTERACTIONS

Carisoprodol

The sedative effects of carisoprodol and other CNS depressants (e.g., alcohol,
benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore,
caution should be exercised with patients who take more than one of these CNS
depressants simultaneously. Concomitant use of carisoprodol and meprobamate,
a metabolite of carisoprodol, is not recommended (see WARNINGS,
Sedation).

Carisoprodol is metabolized in the liver by CYP2C19 to form
meprobamate (see CLINICAL PHARMACOLOGY). Coadministration of CYP2C19
inhibitors, such as omeprazole or fluvoxamine, with carisoprodol could result
in increased exposure of carisoprodol and decreased exposure of meprobamate.
Co-administration of CYP2C19 inducers, such as rifampin or St. John's Wort,
with carisoprodol could result in decreased exposure of carisoprodol and
increased exposure of meprobamate. Low dose aspirin also showed an induction
effect on CYP2C19. The full pharmacological impact of these potential
alterations of exposures in terms of either efficacy or safety of carisoprodol
is unknown.

Aspirin

Clinically important interactions may occur when certain drugs or alcohol
are administered concomitantly with aspirin.

Alcohol

Anticoagulants

Concomitant use of aspirin with anticoagulants (e.g., heparin, warfarin, clopidogrel)
increases the risk of GI bleeding (see WARNINGS,
Serious Gastrointestinal Adverse Reactions). Additionally, aspirin can displace
warfarin from protein binding sites, leading to prolongation of the international
normalized ratio (INR).

Antihypertensives

The concomitant administration of aspirin with angiotensin
converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs),
beta-blockers, and diuretics may diminish the hypotensive effects of these
anti-hypertensive products due to aspirin's inhibition of renal prostaglandins,
which may lead to decreased renal blood flow and increased sodium and fluid
retention. Concomitant use of aspirin and acetazolamide can lead to high serum
concentrations of acetazolamide due to competition at the renal tubule for
secretion.